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Terminated

Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions

FDA Recall Z-0639-04 · Posted 2004-07-20

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeMPB
Date Initiated2004-02-18
Date Terminated2004-08-19
Product Quantity6610 UNITS

Reason for Recall

catheter slips out of the suture wing during use.

Firm Action

The recalling firm issued a recall letter dated 2/18/04 to their direct accounts informing them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The product was shipped to hospitals, medical supply companies, and sales representatives nationwide. Products were also shipped to England, Belgium, Germany, Greece, Sweden, Ukraine, France, Taiwan, Australia, Netherlands, and Denmark.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROArrow Intl., Inc. · 2000-09-14K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITArrow Intl., Inc. · 1999-05-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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